Atherosclerosis, Endothelial Dysfunction, Peri-Implantitis, Peri-implant Mucositis
Conditions
Brief summary
A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with peri-implantitis/peri-implant mucositis and without any cardiovascular disease.
Detailed description
A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with peri-implantitis/peri-implant mucositis and without any cardiovascular disease. 90 patients: 30 with peri-implantitis, 30 with peri-implant mucositis and 30 healthy controls and without periodontitis history. All the patients are assessed for clinical, periodontal, blood and non-invasive ultrasound cardiovascular parameters. Measurements are taken before and after initial periodontal treatment in the peri-implantitis/peri-implant mucositis subjects.
Interventions
PROCEDURENon-surgical periodontal treatment
Subgingival biofilm ultrasonic debridement
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Sealed envelopes
Intervention model description
The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
PERI-IMPLANTITIS GROUP Inclusion Criteria: • Clinically diagnosed with peri-implantitis according to the EFP/AAP 2017 criteria.
Exclusion criteria
* Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months. * Pregnancy. * Cardiovascular Diseases. PERI-IMPLANT MUCOSITIS GROUP Inclusion Criteria: • Clinically diagnosed with peri-implant mucositis according to the EFP/AAP 2017 criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse Wave Velocity carotid-femoral (PWV-CF) | 8 weeks | The speed of pulse wave propagation between carotid-femoral sites |
| Pulse Wave Velocity carotid-femoral (PWV-CR) | 8 weeks | The speed of pulse wave propagation between carotid-radial sites |
| Carotid Intima-Media Thickness (CIMT) | 8 weeks | The thickness of the carotid intima and media |
| Distensibility Coefficient (DC) | 8 weeks | The relative change in luminal area during systole for a given pressure change (pulsed pressure), will be calculated assuming the lumen to be circular. |
| Advanced Glycation End products (AGEs) | 8 weeks | A group of endogenous heterogeneous compounds that are constantly formed under physiological conditions with prooxidant and cytotoxic properties. Measurements are performed by fluorescence spectroscopy technique. |
Countries
Italy
Contacts
Primary ContactGaetano Isola, PhD
Outcome results
None listed